Abbott Medical recalls Proclaim XR 5 Implantable Pulse Generators (Model 3660) due to patients being unable to exit MRI mode. This affects spinal cord stimulation devices used with MRI scans.
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Abbott Medical is recalling Proclaim XR 5 Implantable Pulse Generators (Model 3660) because patients have reported being unable to exit MRI mode. This device is used for spinal cord stimulation and may interfere with MRI scans if not properly managed.
The device's inability to exit MRI mode during scans can cause patients to remain in the MRI sequence longer than intended. This may lead to discomfort or incomplete scans but does not pose a direct safety risk like injury or death.
Patients with spinal cord stimulation devices using this model are affected. The risk is low as the issue only impacts MRI mode exit, not immediate safety.
Check for the model number 3660 on the device. The product is used for spinal cord stimulation and has specific serial numbers listed in the recall notice.
Look for the model number 3660 on the device or its packaging.
Abbott Medical has received complaints that patients are unable to exit MRI mode on their Proclaim XR 5 Implantable Pulse Generators (Model 3660).
The issue only affects MRI mode exit, which may cause discomfort or incomplete scans but does not pose a direct safety risk like injury or death.
Check for the model number 3660 on the device or its packaging. The product is used for spinal cord stimulation.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2505-2023 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2505-2023 from Abbott Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
